a7019k
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of April 2024
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Issued:
16 April 2024, London UK
GSK's 5-in-1 meningococcal ABCWY vaccine candidate accepted for
regulatory review by US FDA
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Vaccine candidate
provides broad coverage against the five most common groups of
bacteria causing invasive meningococcal disease and could reduce
number of injections to simplify immunisation, if
approved
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Prescription Drug
User Fee Act action date set by FDA for 14 February
2025
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Submission based on
results from pivotal phase III trial showing all primary endpoints
met
GSK plc
(LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) has accepted for review a Biologics License
Application (BLA) for its 5-in-1 meningococcal ABCWY (MenABCWY)
vaccine candidate. The Prescription Drug User Fee Act (PDUFA)
action date for a regulatory decision by the US FDA on this
application is 14 February 2025.
GSK's 5-in-1 MenABCWY vaccine candidate combines the antigenic components of its two
well-established meningococcal vaccines with demonstrated efficacy
and safety profiles, Bexsero (Meningococcal Group B Vaccine)
and Menveo (Meningococcal [Groups A, C, Y, and W-135]
Oligosaccharide Diphtheria CRM197 Conjugate Vaccine). The MenABCWY
combination will target the five groups of the
bacteria Neisseria
meningitidis (Men A, B,
C, W and Y) that cause most invasive meningococcal disease (IMD)
cases globally.[1]
Combining
the protection offered by these vaccines into fewer shots aims to
reduce the number of injections, simplifying immunisation. This can
help increase series completion and vaccination coverage and help
reduce the overall burden of IMD, with unvaccinated adolescents
being at particular risk of infection and potential
outbreaks.[2],[3],[4]
IMD is an unpredictable but serious illness that can cause
life-threatening complications.[5] Despite treatment, among those who contract
IMD one in six will die, sometimes in as little as 24
hours.[6],[7] One in five survivors may
suffer long-term consequences such as brain damage,
amputations, hearing loss and nervous system
problems.[8] Although anyone can get IMD, those who are
in their late teens and early adulthood are amongst the groups at
higher risk of contracting it.[9],[10]
In the US, while meningococcal vaccine recommendations for all five
serogroups have been in place since 2015, annual immunisation rates
for IMD have remained low overall, due in part to a complex
schedule.[11] MenB is the most common group of
IMD-causing bacteria in US adolescents and young adults, accounting
for more than half of the IMD cases among this age group in the US
from 2017-2021.[12] For protection against MenB, which is subject to
the shared clinical decision-making recommendation of the CDC, just
under 12% of US adolescents have had the two required
doses.10
In the phase III trial (NCT04502693),
all primary endpoints were achieved for the MenABCWY vaccine
candidate, including immunological non-inferiority to one dose of
GSK's Meningococcal Groups A,C,Y and W
Vaccine, and non-inferior immune responses against 110 diverse
MenB invasive strains (representing 95% of MenB strains circulating
in the US) as compared to two doses of GSK's Meningococcal
Group B Vaccine. The vaccine was well tolerated with a
safety profile consistent with both vaccines.[13]
About the MenABCWY phase III trial
The trial conducted by GSK was a phase III randomised, controlled,
observer-blind, multi-country trial to evaluate the safety,
tolerability and immunogenicity of GSK's MenABCWY vaccine
candidate. The trial started in August 2020, and
approximately 3,650 participants aged 10-25 were enrolled in the
US, Canada, Czech Republic, Estonia, Finland, Turkey and
Australia.
The
objective of the trial was to assess the safety profile of the
MenABCWY vaccine candidate, to assess the
immunological vaccine effectiveness against a panel of 110 MenB
strains and to demonstrate non-inferiority of the immune responses
of the trial's participants who received two doses of the MenABCWY
vaccine candidate six months apart to the responses of those in the
control groups who received GSK's licensed vaccines: two doses
of Meningococcal Group B Vaccine and one dose
of Meningococcal Groups A,C,Y and W
Vaccine.
About Bexsero
Bexsero is currently
licensed or has received regulatory approval in 55 countries,
including the US and EU, and is used in 16 national immunisation
programmes worldwide for the prevention of IMD caused
by Neisseria
meningitidis serogroup
B. In the US, it is licensed under the Accelerated Approval
pathway for active immunisation to prevent IMD caused
by Neisseria
meningitidis serogroup B
in individuals from 10 through 25 years. As required under the
FDA's Accelerated Approval regulations, GSK has completed a
confirmatory trial of this vaccine and submitted a supplemental
Biologics License Application (sBLA) to convert the accelerated
approval to full approval. The US Prescribing Information is
available here.[14]
About Menveo
Menveo has received
regulatory approval in over 60 countries, including the US, with
more than 72 million doses distributed worldwide since 2010. It
offers extensive evidence of immunogenicity with a
well-characterised safety profile. In the US, this vaccine has
received regulatory approval for active immunisation to prevent IMD
caused by Neisseria
meningitidis serogroups A,
C, Y, and W in individuals from 2 months through 55 years of age.
The US Prescribing Information is
available here.[15]
About GSK
GSK is
a global biopharma company with a purpose to unite science,
technology, and talent to get ahead of disease together. Find out
more at gsk.com.
GSK enquiries
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Media:
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Tim
Foley
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+44 (0)
20 8047 5502
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(London)
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Simon
Moore
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+44 (0)
20 8047 5502
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(London)
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Kathleen
Quinn
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+1 202
603 5003
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(Washington
DC)
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Alison
Hunt
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+1 540 742 3391
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(Washington
DC)
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Investor
Relations:
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Nick
Stone
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+44 (0)
7717 618834
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Mick
Readey
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+44 (0)
7990 339653
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(London)
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Josh
Williams
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+44 (0)
7385 415719
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(London)
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Camilla
Campbell
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+44 (0)
7803 050238
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(London)
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Steph
Mountifield
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+44 (0)
7796 707505
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Frannie
DeFranco
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+1 215
751 4855
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(Philadelphia)
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Cautionary statement regarding forward-looking
statements
GSK cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described under Item 3.D
"Risk factors" in the company's Annual Report on Form 20-F for
2023.
Registered
in England & Wales:
No.
3888792
Registered
Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
[1]. CDC. Meningococcal
Disease Causes and How It Spreads. Available at: https://www.cdc.gov/meningococcal/about/causes-transmission.html.
Accessed April 2024.
[2].
Bekkat-Berkani R, Fragapane E, Preiss S, Rappuoli R et
al. Public health perspective
of a pentavalent meningococcal vaccine combining antigens of
MenACWY-CRM and 4CMenB, Journal of Infection Vol 85,
Issue 5, p481-491, published November 2022.
[3].
Huang L, Snedecor S et al. Potential public health impact of a Neisseria
meningitidis A, B, C, W, and Y pentavalent vaccine in the United
States, Postgraduate Medicine, 134(4):341-348 published
May 2022.
[4].
CDC. University-Based
Outbreaks of Meningococcal Disease Caused by Serogroup B, United
States, 2013-2018 - Volume 25, Number 3-March 2019 -
Emerging Infectious Diseases journal - CDC. Available at:
https://wwwnc.cdc.gov/eid/article/25/3/18-1574_article. Accessed
April 2024.
[5]. CDC. Bacterial
Meningitis, Available
at: www.cdc.gov/meningitis/bacterial.html. Accessed
April 2024.
[6]. World Health Organisation. Meningitis fact
sheet. Available
at: https://www.who.int/news-room/fact-sheets/detail/meningitis.
Accessed April 2024.
[7].
Thompson MJ et al. Clinical
recognition of meningococcal disease in children and
adolescents. Lancet. 2006. 367, 397-403.
[8]. CDC. Meningococcal disease:
clinical information.
Available at: https://www.cdc.gov/meningococcal/clinical-info.html.
Accessed April 2024.
[9].
McNamara LA, Blain A. Meningococcal Disease Roush SW,
Baldy LM, Hall MAK, eds. Manual for the Surveillance of
Vaccine-Preventable Diseases. Centers for Disease Control and
Prevention. Reviewed January 5, 2022. Accessed April
2024.
[10]. Pingali C, Yankey D, Elam-Evans
LD, et al. Vaccination
coverage among adolescents aged 13-17 years - National Immunization
Survey-Teen, United States, 2022. MMWR 2023; 72(34):
912-919.
[11]. Schillie S. Revising the Adolescent
Meningococcal Vaccine Schedule: Term of Reference and
Considerations. Available
at: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2024-02-28-29/02-Meningitis-Schillie-508.pdf.
Accessed April 2024.
[12]. CDC. Enhanced Meningococcal
Disease Surveillance Reports, 2017-2021. Available at: www.cdc.gov/meningococcal/surveillance/index.html#enhanced-reports.
Accessed April 2024.
[13]. NIH. Effectiveness of GlaxoSmithKline Biologicals
S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy
Adolescents and Young Adults, ClinicalTrials.gov. Available
at: https://clinicaltrials.gov/study/NCT04502693.
Accessed April 2024.
[14]. GSK. Highlights Of Prescribing Information Bexsero. Available
at: gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Bexsero/pdf/BEXSERO.PDF.
Accessed April 2024.
[15]. GSK. Highlights Of Prescribing Information Menveo. Available
at: gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Menveo/pdf/MENVEO.PDF.
Accessed April 2024.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GSK plc
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(Registrant)
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Date: April
16, 2024
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By:/s/ VICTORIA
WHYTE
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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